QAW039 in moderate to severe asthma.

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, study examining the effect of orally administered QAW039 (225 mg BID) on sputum eosinophil levels and other efficacy outcomes in patients with sputum eosinophilia and persistent asthma.

• IRAS ID

  92275

• Contact name

  Christopher Brightling

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2011-004966-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Many patients with moderate to severe asthma are treated with inhaled corticosteroids (ICS) or combinations of ICS and long-acting beta-agonists (LABA), however still fail to achieve adequate control of their symptoms on a day to day basis or when their symptoms worsen (called exacerbations). These patients may not respond to therapies such as these inhalers due to factors which include poor adherence to medication and inadequate inhaler technique. Sometimes a patient may simply not respond to corticosteroids (corticosteriod resistance). Furthermore, there is evidence that some patients with asthma have prominent small airway disease (small airways in the lungs) that cannot be reached by standard inhalers. Such patients may require systemic (oral) therapy to control their airway inflammation. Current treatment options include the addition of a leukotriene modifier such as montelukast, but not all patients respond to this, and a significant proportion require step-up to long-term oral corticosteroids to achieve control. Long term or high doses of corticosteriods are an unattractive option given the well-known side-effects of osteoporosis, muscle wasting and bruising. There is thus a need for effective oral anti-inflammatory therapies for asthma with greater efficacy than montelukast. We therefore propose a single-centre, randomised, placebo-controlled clinical trial to determine if 12 weeks of treatment of QAW039 in patients with persistent asthma is of therapeutic benefit to these patients in addition to reducing levels of eosiniophils (a marker of airway inflammation) in sputum, improving lung function and lung pathology.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0402

• Date of REC Opinion

  16 Dec 2011

• REC opinion

  Further Information Favourable Opinion